Licence variation: spironolactone for acne in women market engagement

Descriptions

NHS England has published this Preliminary Market Engagement Notice. It is anticipated that there will be two separate contracts to deliver this, as outlined below. • Contract A: Prepare an application for a major (type II) MHRA Marketing Authorisation variation for spironolactone. • Contract B: Submit the pre-prepared application to the MHRA. Only current Marketing Authorisation Holders of spironolactone are eligible to bid for contract B. The licence variation is to add a new indication to the current licence (marketing authorisation) for spironolactone, for treating acne in women. For contract A, the Successful Supplier would need to prepare a dossier for the MHRA including: • A Risk Management Plan • Clinical Overview • Revised Summary of Product Characteristics and Patient Information Leaflet • Responses to the MHRA's Request(s) for Further Information. For contract B, the Successful Supplier would need to: • Review the draft regulatory modules and supporting documents prepared by contractor A and either confirm they are complete, or request revisions. • Use the final regulatory modules and supporting documents to apply for a major type II licence variation from the MHRA. • If granted, update the Summary of Product Characteristics and Patient Information Leaflet with the new indication and related data. NHS England would like to gather soft intelligence from the market and is publishing a Request for Information for the two contracts. NHS England would also be pleased to offer 1:1 meetings with potential Suppliers to discuss this innovative partnership approach. The Request for Information and further documentation will be available from 26 February 2025 and the deadline for responses will be 14 March 2025 at 12 noon and 1:1 meetings will be 12 noon on 11 March 2025. To register an interest in responding to this market engagement exercise and obtain a copy of the Request for Information documentation please go to: http://health.atamis.co.uk. All communications and Request for Information submissions will be conducted via Atamis. The portal can be accessed at any time of the day and it is free to register. This notice signals the intention to conduct an information gathering exercise only. This notice does not constitute a call for competition in its own right. Publication of this notice and/ or any responses to it does not commit NHS England and/or respondents to undertaking or participating in any future procurement process, nor does it provide any process exemptions or preferential treatment to any parties expressing an interest. NHS England will not be liable for costs incurrent by any interested party in participating in the information exercise howsoever arising.